Associate - Regulatory Affairs (API)
About the Role
Roles & Responsibilities
• Prepare and compile API regulatory dossiers (CTD / eCTD)
• Handle DMF submissions, responses, and lifecycle management
• Coordinate with R&D, QA, and cross-functional teams for documentation
• Review, update, and maintain regulatory documents as per guidelines
• Support regulatory compliance activities for API products
Qualification
• M.Sc in a relevant discipline
Experience
• 1 year of experience in Regulatory Affairs (API)
Skills
• Knowledge of ICH, USFDA, EMA, and global regulatory guidelines
• Strong documentation and dossier preparation skills
• Good communication and coordination abilities
About the Organization
Cadila Pharmaceuticals Limited is a well-established Indian pharmaceutical company with a strong presence in APIs and finished formulations. Known for its quality-driven approach, Cadila operates globally and complies with major international regulatory standards.
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